Sunday, 22 July, 2018

Medical Milestone: FDA OKs Marijuana-Based Drug For Seizures

AP  File 2017		GW Pharmaceuticals’ Epidiolex a medicine made from the marijuana plant AP File 2017 GW Pharmaceuticals’ Epidiolex a medicine made from the marijuana plant
Judith Alexander | 28 June, 2018, 11:21

Rite Aid and other USA pharmacies could soon sell a drug derived from cannabis. "But it's also important to note that this is not an approval of marijuana or all of its components".

"Some of these companies are going to be great and truly add value to the consumer and some of these companies are going to be awful and their primary focus is going to be for profit", one startup CEO told Business Insider.

FDA approves marijuana-derived drug, the prescription cannabidiol medicine to treat seizures in a subset of patients suffering from rare and severe epilepsy.

The prescription formulation of Epidiolex is a highly purified cannabidiol (CBD) derived from the marijuana plant but lacking the psychoactive ingredient most people associate with marijuana. CBD has been proven to have many medical applications, including pain-relief, combating anxiety, reducing the risk of diabetes, treating sleep issues, and in the case, helping treat seizures.

Other marijuana products are not necessarily subject to these standards, or even basic stipulations that ensure cleanliness and proper ingredient concentrations.

Still, uncertainty has left consumers across the country in mass confusion, wondering whether they can legally purchase these products, and concerned about law enforcement repercussions if they do.

Gaer said she's been using a particular CBD oil with her daughter since it's been legal in Iowa, and she's not sure about this new drug. "Some of these companies are going to be great and truly add value to the consumer and some of these companies are going to be bad and their primary focus is going to be for profit". Before Epidiolex can be legally brought to market the FDA will have to reclassify CBD which is now listed on Controlled Substance Schedule 1 alongside illicit narcotics such as LSD, cocaine, and heroin making them illegal on the federal level, even though CBD has been made legal in most states.

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How will the DEA handle CBD?

Epidiolex will be marketed in the United States by GW's USA subsidiary, Greenwich Biosciences. Epidiolex contains less than 0.1% of tetrahydrocannabinol (THC), which can make people high.

"It's a great step in the direction of ending some of the stigma with medical marijuana". And 18 of the samples tested positive for THC, despite it not being listed on the label. Researchers and patients hope it will open the door for more research on cannabis. The proposals generally sought to remove CBD from states' legal definition of marijuana, allowing it to be prescribed by doctors and supplied by pharmacies.

An FDA advisory committee recommended approval of Epidiolex in April; it had until this week to make a decision on the recommendation. Canada will become the 5th Western country standing to possibly make a fortune by fully legalizing cannabis on a nationwide level joining countries such as Uruguay, Spain, Norway, and Switzerland, while the U.S. takes tentative steps forward towards legalization.

Reclassification of CBD could set the stage for the approval of other cannabis-derived medications.

That said, companies should be careful. "We're just now really understanding cannabinoids and the breadth of what they can do".

That remains to be seen.

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